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Eloxatin (Oxaliplatin) - Summary

 



WARNING

ELOXATIN (oxaliplatin injection) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

Anaphylactic-like reactions to ELOXATIN have been reported, and may occur within minutes of ELOXATIN administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms (see WARNINGS and ADVERSE REACTIONS).

 

ELOXATIN SUMMARY

ELOXATIN(oxaliplatin for injection) is an antineoplastic agent. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group.

ELOXATIN, used in combination with infusional 5-FU/LV, is indicated for the treatment of advanced carcinoma of the colon or rectum.


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NEWS HIGHLIGHTS

Media Articles Related to Eloxatin (Oxaliplatin)

Amgen Announces Overall Survival Results For Vectibix(R) In First-Line Metastatic Colorectal Cancer
Source: Colorectal Cancer News From Medical News Today [2009.11.06]
Amgen (Nasdaq: AMGN) announced that the Phase 3 PRIME "203" trial evaluating Vectibix® (panitumumab) administered in combination with FOLFOX (an oxaliplatin-based chemotherapy) as a first-line treatment of metastatic colorectal cancer (mCRC) failed to meet a secondary endpoint of overall survival.

Poniard Pharmaceuticals Announces Updated Positive Clinical Data From Phase 2 Trial Of Picoplatin In Colorectal Cancer
Source: Colorectal Cancer News From Medical News Today [2009.11.18]
Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) announced updated clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC).

'Cross-talk' Mechanism Contributes To Colorectal Cancer
Source: Colorectal Cancer News From Medical News Today [2009.11.14]
Researchers at the University of Wisconsin-Madison School of Medicine and Public Health have identified a molecular mechanism that allows two powerful signaling pathways to interact and begin a process leading to colorectal tumors. "We are very excited about these findings," says Vladimir Spiegelman, an associate professor of dermatology. "Drugs could be developed to block this mechanism and prevent colorectal cancer, which affects millions of people worldwide.

African-Americans With Colorectal Cancer Have Poorer Outcomes, Lower Survival Rates
Source: Colorectal Cancer News From Medical News Today [2009.11.13]
New research published in the November issue of the Journal of the American College of Surgeons shows that African-American patients with colorectal cancer are more likely to be diagnosed with advanced disease and are less likely to undergo surgical procedures compared with Caucasians, suggesting that improvements in screening and rates of operation may reduce differences in colorectal cancer outcomes for African-Americans.

Gastrocor(R) Introduces New FISH Test For Colorectal Cancer Detection
Source: Colorectal Cancer News From Medical News Today [2009.11.02]
GastroFISH™ is the first tissue-based fluorescence in situ hybridization (FISH) test for the detection of chromosomal anomalies associated with colon cancer. "We are excited to be the first laboratory to offer GastroFISH for the colon. Using current histological techniques, identifying adenomas with a high risk for progression to cancer is not possible.

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Published Studies Related to Eloxatin (Oxaliplatin)

Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group. [2009.08.10]
PURPOSE: Single-agent gemcitabine (GEM) is standard treatment of metastatic pancreatic cancer. Fixed-dose rate (FDR) GEM and GEM plus oxaliplatin have shown promise in early clinical trials. E6201 was designed to compare overall survival (OS) of standard weekly GEM 1,000 mg/m(2)/30 minutes versus GEM FDR 1,500 mg/m(2)/150 minutes or GEM 1,000 mg/m(2)/100 minutes/day 1 plus oxaliplatin 100 mg/m(2)/day 2 every 14 days (GEMOX)... CONCLUSION: Neither GEM FDR nor GEMOX resulted in substantially improved survival or symptom benefit over standard GEM in patients with advanced pancreatic cancer.

Explorative study to identify novel candidate genes related to oxaliplatin efficacy and toxicity using a DNA repair array. [2009.07.21]
PURPOSE: To identify new polymorphisms (single nucleotide polymorphisms, SNPs) in DNA repair pathways that are associated with efficacy and toxicity in patients receiving oxaliplatin and capecitabine for advanced colorectal cancer (ACC). METHODS: We studied progression-free survival (PFS) in 91 ACC patients, of whom germ-line DNA was isolated and genotyped using an Asper Biotech array...

Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. [2009.07.01]
PURPOSE Three-year disease-free survival (DFS) was significantly improved in patients who had undergone resection with curative intent for stage II or III colon cancer who received bolus plus continuous-infusion fluorouracil plus leucovorin (LV5FU2) with the addition of oxaliplatin (FOLFOX4)... CONCLUSION Adding oxaliplatin to LV5FU2 significantly improved 5-year DFS and 6-year OS in the adjuvant treatment of stage II or III colon cancer and should be considered after surgery for patients with stage III disease.

Phase III noninferiority trial comparing irinotecan with oxaliplatin, fluorouracil, and leucovorin in patients with advanced colorectal carcinoma previously treated with fluorouracil: N9841. [2009.06.10]
PURPOSE: The primary goal of this multicenter phase III trial was to determine whether overall survival (OS) of fluorouracil (FU) -refractory patients was noninferior when treated with second-line infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4; arm B) versus irinotecan (arm A). Cross-over to the other treatment on disease progression was mandated... CONCLUSION: In patients who experienced treatment failure with front-line FU therapy, OS does not significantly differ whether second-line therapy begins with irinotecan or FOLFOX4. FOLFOX4 produces higher RR and longer TTP. Both arms had notable OS in patients who experienced treatment failure with first-line FU therapy.

Administration of reduced glutathione in FOLFOX4 adjuvant treatment for colorectal cancer: effect on oxaliplatin pharmacokinetics, Pt-DNA adduct formation, and neurotoxicity. [2009.06]
Oxaliplatin is a promising drug for cancer therapy and the oxaliplatin/5-fluorouracil/leucovorin (FOLFOX) regimen has become the standard adjuvant treatment for colorectal cancer. However, the oxaliplatin-induced neurotoxicity still represents a clinical problem leading to a discontinuation of the therapy...

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Clinical Trials Related to Eloxatin (Oxaliplatin)

XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer [Active, not recruiting]
XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes).

Bloodsamples will be collected and frozen and later examined for potential predictive factors

Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma [Active, not recruiting]
This is a Phase II trial of the combination of oxaliplatin (Eloxatin) and capecitabine (Xeloda), known as XELOX, in patients with unresectable or recurrent cholangiocarcinoma, including carcinoma of the gallbladder or biliary tract, both intrahepatic and extrahepatic. Patients may be either previously untreated or treated with chemotherapy. Patients will accrue to two strata based on pre-treatment status; separate response rates and statistical operating characteristics will be applied to each stratum.

The primary objective is to determine the objective response rate (complete plus partial) of XELOX in this population.

Secondary objectives include determining toxicity, stable disease rates, and median and overall survival of patients treated with this combination.

A Phase II Study of Eloxatin and Alimta in Combination With Bevacizumab in Advanced Non-Squamous NSCLC [Active, not recruiting]
This is a Phase II, open-label, non-randomized study in patients with advanced non-squamous NSCLC.

Each cycle will be 21 days. Patients will be evaluated every 2 cycles (~6 weeks) for response using RECIST criteria. Those patients achieving stable disease or better will continue therapy. Those patients experiencing progressive disease will be taken off study.

Patients will receive 6 cycles of Eloxatin, Alimta, and Bevacizumab. After the 6 cycles, patients will receive Bevacizumab alone every 21 days until evidence of disease progression or unacceptable toxicity.

Note: Once patient has completed the 6 cycles of Eloxatin, Alimta, and Bevacizumab and is receiving single-agent Bevacizumab, assessment of response will be performed every 3 cycles (~every 9 weeks) using RECIST criteria.

Endometrial Cancer - LOHP Alone and With 5FU [Completed]
To determine the efficacy (response rate [RR], time to progression and survival) of oxaliplatin as a single agent and oxaliplatin in combination with 5 FU in patients with advanced/metastatic endometrial cancer pretreated with one prior chemotherapy regimen containing cisplatin (CDDP) or carboplatin and to define the safety profile of each arm of the above mentioned regimens in these patients

Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer [Active, not recruiting]
The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.

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Page last updated: 2009-11-18

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